Pleural Neoplasm Clinical Trial
Official title:
A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.
| Status | Recruiting |
| Enrollment | 208 |
| Est. completion date | April 30, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Outpatients with MPE undergoing IPC placement - Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions - Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter Exclusion Criteria: - Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) - Inability or unwillingness to give informed consent - Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC) - Pregnancy - Previous intrapleural therapy for MPE on the same side - Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =< 2 weeks - Doxycycline allergy - Extensive loculations or hydropneumothorax or other contraindication to pleurodesis - Chylous effusions associated with malignant disease |
| Country | Name | City | State |
|---|---|---|---|
| United States | M D Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to pleural catheter removal | This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal. | Up to 1 year | |
| Secondary | Recurrence of effusion requiring drainage after IPC | Up to 1 year | ||
| Secondary | Indwelling pleural catheters (IPC) complications | Up to 1 year | ||
| Secondary | Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D) | Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement. | Baseline up to 1 year | |
| Secondary | Change in dyspnea using Borg score | Will use paired t-test to compare baseline and 1 month Borg scores and utilities. A generalized linear model will be used to evaluate whether other variables have any impact on the pairwise differences between baseline and 1 month. | Baseline up to 1 year | |
| Secondary | Assessment of symptom burden | Baseline up to 1 year | ||
| Secondary | Procedure-associated pain | Up to 1 year | ||
| Secondary | Need for hospitalization due to pleurodesis pain | Up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05672108 -
Transarterial Chemoembolization for the Treatment of Lung Cancer
|
Phase 2 |